NT-proBNP to Assess Trastuzumab-induced Cardiotoxicity

Launched by VASTRA GOTALAND REGION · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how trastuzumab, a treatment for HER2 positive breast cancer, affects the heart. The researchers want to see if measuring a substance called NT-proBNP in the blood can help detect heart problems that may be caused by this treatment. Patients with HER2 positive breast cancer will have their NT-proBNP levels checked before starting trastuzumab and again at 6 and 12 months into the treatment. If these levels go up, they will undergo further heart tests using echocardiography or a special scan. The goal is to find out if NT-proBNP can safely replace these heart tests in monitoring potential heart damage.

To be eligible for this trial, participants need to be at least 18 years old and have confirmed HER2 positive breast cancer that is being treated with chemotherapy and HER2 blocking agents. They should also have good overall health, no serious heart conditions, and no other active cancers (except for certain skin cancers). Participants will need to provide consent and follow the study procedures, which include regular blood tests and heart assessments during their treatment. This trial is currently recruiting patients of all genders and is an important step in improving the safety of breast cancer treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histological confirmed HER2 positive primary BC planned for adjuvant/neoadjuvant treatment with chemotherapy plus HER2 blocking agents.
• • 2. Patients ≥18 years
• • 3. ECOG/WHO 0-1
• • 4. Adequate organ function for the planned treatment according to local guidelines.
• • 5. No distant metastasis (CT/MRI only if clinically indicated).
• • 6. Negative pregnancy test within 14 days prior to start of treatment.
• • 7. If of childbearing potential, willing to use an effective form of contraception.
• • 8. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
• • 9. Signed informed consent and willingness to follow the trial procedures.
• Exclusion Criteria:
• • 1. Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment.
• • 2. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
• • 3. Pregnancy and breast feeding.
• • 4. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
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